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IRCT20120527009878N7 IRCT 2019-05-16 Tabriz University of Medical Sciences effectivness of amantadine hydrocholoride on functional recovery in sever traumatic brain injery effectivness of amantadine hydrocholoride on functional recovery in sever traumatic brain injery 2019-06-16 anticipated 60 Complete https://irct.ir/trial/39378 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The accident will be the case with two boxes, each containing blue and red cards, one of which represents a placebo and the other representing Amantadine, and only the head nurse of Tabriz Imam Resa Hospital and the medical staff of This will be known and will place one of the colored stickers in the patient's case. Three months later, the examiner will examine the patient without notifying which treatment method has been chosen and will record the patient's radiological criteria, Blinding description: The selected patients will be divided into two groups of placebo recipients and amantadine recipients based on the color of the card, which the head nurse will be informed of. The next month, the examiner examined the patient without knowing which treatment method was selected, and the radiological criteria It will be recorded for the patient, which is also a type of treatment methodology, and therefore on this basis, the study will be blinded to three parts, and after the analysis, the head and nurse will be asked the type of blue and red method. N/A Level of consciousness and cognitive function in patients with trauma. Intervention 1: Intervention group: Patients aged 18 to 65 years with severe brain trauma will receive twice daily Amantadine 100 mg once a day, and this dose will continue for 11 days. At week 3, the dose will be increased to 150 mg twice a week and week 4 to 200 mg twice weekly. Intervention 2: Control group: Patients aged 18 to 65 years with severe brain trauma will receive placebo once a day after an accident at a dose of 100 mg of amantadine twice daily and will continue for 11 days. At week 3, the dose will be increased to 150 mg twice a week and at week 4 to 200 mg twice a week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Moslem Shakeri
Golgasht ave
ُTabriz Iran (Islamic Republic of) 5166614756 +98 44 1333 8507 shakerim@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Ahsan Rahimi
Golgasht ave
Tabriz Iran (Islamic Republic of) 5166614756 +98 44 1343 8707 Rahimiahsan@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 1- Patients aged 18 to 65 years 2. Those who have not had a known disease prior to head injury. 3. The supervisor will provide his written consent on his behalf 18 years 65 years Both 1-People with severe cardiovascular disease or congestive heart failure, myocardial infarction, persistent spinal cord injury, cancer, or any other severe disease that affects the evaluation of treatment. 2-People with chronic steroid therapy 3-Individuals received any other drug within 30 days of injury. 4-Significant TBI, brain tumor, cerebrovascular event, or other persistent brain illusions Treatment - Drugs Placebo Intervention group: Patients aged 18 to 65 years with severe brain trauma will receive twice daily Amantadine 100 mg once a day, and this dose will continue for 11 days. At week 3, the dose will be increased to 150 mg twice a week and week 4 to 200 mg twice weekly. Control group: Patients aged 18 to 65 years with severe brain trauma will receive placebo once a day after an accident at a dose of 100 mg of amantadine twice daily and will continue for 11 days. At week 3, the dose will be increased to 150 mg twice a week and at week 4 to 200 mg twice a week. Mini-mental Status Test (MMSE) scoring for patients with severe acute trauma. Timepoint: During surgery and duration of hospitalization after surgery. Method of measurement: Check out the Mini-mental Status Test (MMSE) table. Disability Rating Scale (DRS) scoring for patients with severe acute traumatic brain injury. Timepoint: During surgery and duration of hospitalization after surgery. Method of measurement: Disability Rating Scale (DRS) Score. Glasgow Outcome Scale Scoring (GOS) for patients with severe acute traumatic brain injury. Timepoint: During surgery and duration of hospitalization after surgery. Method of measurement: Check Glasgow Outcome Scale Table (GOS). Tabriz University of Medical Sciences Approved 2019-05-07 Ethics Committee of Tabriz Medical School Azadi Ave , Golghast St , Imam Reza Hospital Tabriz East Azarbaijan Iran (Islamic Republic of)